Registration Dossier
Registration Dossier
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EC number: 225-918-0 | CAS number: 5146-66-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Monograph on fragrance raw material-Geranyl nitrile
- Author:
- José L. Domingo
- Year:
- 1 976
- Bibliographic source:
- Food and Cosmetics Toxicology Volume 14, Supplement, 1976, Pages 787
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Maximization test was performed to evaluate the skin sensitization potency of Geranyl nitrile on human.
- GLP compliance:
- not specified
- Type of study:
- other: maximization test
Test material
- Reference substance name:
- 3,7-dimethylocta-2,6-dienenitrile
- EC Number:
- 225-918-0
- EC Name:
- 3,7-dimethylocta-2,6-dienenitrile
- Cas Number:
- 5146-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- 3,7-dimethylocta-2,6-dienenitrile
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): GERANYL NITRILE
- Molecular formula: C10H15N
- Molecular weight: 149.236 g/mol
- Smiles notation : N#C\C=C(\CC\C=C(\C)C)C
- InChl: 1S/C10H15N/c1-9(2)5-4-6-10(3)7-8-11/h5,7H,4,6H2,1-3H3/b10-7+
- Substance type: Organic
- Physical state: Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: No data
- Vehicle:
- petrolatum
- Concentration / amount:
- 12% in petrolatum
Challengeopen allclose all
- Route:
- other: No data
- Vehicle:
- petrolatum
- Concentration / amount:
- 12% in petrolatum
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- No data
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- not sensitizing
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: not sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- According to maximization test,the chemical Geranyl nitrile was found to be non-sensitizing to human volunteers.
- Executive summary:
A maximization test was carried out on 25 volunteers to evaluate the skin sensitizing effects of geranyl nitrile. The test chemical tested at a concentration of 12% in petrolatum.
The volunteers failed to elict any sensitization reaction at the given concentration.
Hence,the chemical Geranyl nitrile (CAS No: 5146 -66 -7) considered to be non-sensitizing .
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